Simcere's 14 new class 1 drugs and 5 blockbuster varieties are the first to be imitated!

Recently, Simcere Pharmaceuticals announced that it has reached a project cooperation with Shanghai Institute of Medicine and others on the global development, production and commercialization of the new coronavirus drug candidate SIM0417 series
.
Simcere, which is at the forefront of innovation and transformation, has seen a 57% increase in revenue from innovative drugs in 2021H1, accounting for about 58% of revenue.
It has become a pharmaceutical company dominated by innovative drug business
.
At present, the company has nearly 60 innovative drug projects under development, and 14 category 1 new drugs are in the clinical application and above stage, of which 4 are already on the market.
In terms of generic drugs, 15 varieties have been reviewed (6 are the first ones), 5 The first imitation of a variety of varieties, of which over $9 billion of large varieties are exclusively reported for production
.
Innovative drug sales accounted for nearly 60%, and medical insurance boosted the volume of Class 1 new drugs.
Simcere Pharmaceuticals, which is committed to rapid transformation to R&D and innovation-driven, has become a pharmaceutical company dominated by innovative drug business, and is an innovative transformation of many traditional pharmaceutical companies.
One of the typical representatives
.
The interim performance report shows that in 2021, Simcere Pharmaceuticals achieved revenue of approximately 2.
12 billion yuan, an increase of 10.
1% over the same period last year.
Among them, the revenue of innovative drugs was approximately 1.
22 billion yuan, an increase of 56.
8% over the same period last year, accounting for 57.
6 percent of total revenue.
%; Net profit is about 555 million yuan, an increase of about 200.
2% over the same period last year
.
Simcere's innovative drug revenue as a proportion of total revenue.
Source: Listed company announcements.
In recent years, Simcere's innovative drug revenue as a percentage of revenue has been increasing year by year, thanks to the first-class new drug edaravone dexcamphanol injection Liquid revenue has grown rapidly.
In 2021, H1's sales of innovative drugs accounted for a new high, reaching 57.
6%
.
Simcere's R&D investment (unit: 100 million yuan) Source: Listed company announcement In 2021, H1 Simcere's R&D investment is about 627 million yuan, an increase of 38% over the same period last year, accounting for 29.
6% of revenue
.
In recent years, Simcere's R&D intensity has been strengthened year by year, from 9.
9% in 2018 to 29.
6% in H1 in 2021, indicating the company's determination and speed to rapidly transform to R&D innovation
.
Simcere currently has 4 innovative drugs approved for marketing, namely edaravone and dextran injection, recombinant human endostatin injection, iramud tablets and abatacept injection
.
Edaravone dextrocampanol injection approved in July 2020 is the only new stroke drug approved in the world in the past five years
.
It was included in the National Medical Insurance Category B list through negotiations within six months of its launch .
According to data from Mi Nei.
com, the terminal sales of this product in 2021H1 China's urban public hospitals, county-level public hospitals, urban community centers, and township health centers (referred to as Chinese public medical institutions) exceed 200 million yuan
.
Also approved in 2020 is the innovative drug abatacept injection introduced by Simcere.
This is the first and only CTLA4-Fc fusion protein approved in China, and it is also the only approved T cell selective costimulation.
Immunomodulator for the treatment of rheumatoid arthritis
.
The product participated in the 2021 medical insurance negotiations.
It is reported that Simcere Pharmaceuticals completed the negotiations in only 25 minutes
.
A new class 1 drug for rheumatoid arthritis, Iramud tablets, is the world’s first and only domestically marketed Irammod drug.
It is a national health insurance category B product and will be available in Chinese public medical institutions and cities in China in 2020.
The total sales of physical pharmacies exceeded 1 billion yuan, a year-on-year increase of 54.
3%
.
At present, the product has new indications and is in Phase II clinical trials for the treatment of Sjogren’s syndrome
.
Recombinant human endostatin injection is the only endostatin approved for marketing at home and abroad, and it is also the first anti-angiogenesis targeted drug in China
.
This product has been included in the medical insurance for many years.
In 2020, the total sales in China's public medical institutions and physical pharmacies in cities in China will exceed 1 billion yuan
.
For this product, Simcere is actively expanding new indications, of which malignant pleural effusion indications are undergoing phase III clinical trials
.
The sound sales promotion system is superimposed on medical insurance, and the revenue of Simcere's innovative drugs has increased rapidly, which has promoted the continuous growth of the company's performance
.
In the future, as more innovative products are successively approved for listing, the company's sales of innovative drugs will continue to increase
.
60 innovative drugs are under development, and 4 new class 1 drugs are expected to be launched.
Relying on the dual-drive model of "cooperation + self-research", Simcere has created an innovative drug pipeline with significant differentiation and great commercial potential
.
As of June 30, the company has nearly 60 innovative drug projects, focusing on the three major disease areas of "central nervous system, autoimmunity, and tumor"
.
The source of some innovative drugs under research by Simcere Pharmaceuticals: Meinenet China Drug Clinical Trial Public Library In the field of anti-tumor, Envolimab, which is cooperating with Siide Di and Corning Jerry, has submitted an NDA and has recently entered the administrative approval stage.
It is expected Become the world's first PD-L1 monoclonal antibody that can be injected subcutaneously; Servacizumab, a new generation of recombinant humanized anti-vascular endothelial growth factor (VEGF) monoclonal antibody, in cooperation with Apexigen of the United States, has a stronger anti-tumor effect.
Phase III clinical trials are currently underway; Trilaciclib, a CDK4/6 inhibitor in cooperation with G1 in the United States, is a CDK4/6 inhibitor with comprehensive bone marrow protective effects.
Phase III clinical trials are currently underway
.
In terms of BD, in March this year, Simcere and Kazia reached a cooperation on Paxalisib (SIM0395), which is a PI3K/mTOR pathway inhibitor for the treatment of glioblastoma.
II/III is being carried out globally.
Clinical application has been submitted in China
.
In the field of central nervous system, edaravone dextrocampanol sublingual tablets (Y-2 sublingual tablets) cooperating with Yantai Yinuoyi is undergoing phase III clinical trials.
The new sublingual administration method is not restricted by the conditions of medical places.
The administration is more convenient, patient compliance is better, and it is more suitable for expanding other central nervous system disease indications in the future; SIM1910-09 for injection (SIM0307) is an aquaporin developed based on the Nobel Prize achievement aqua channel theory 4 (AQP4) inhibitors, ischemic stroke with cerebral edema indications are undergoing phase I clinical trials
.
For BD, in June this year, Simcere and Vivoryon reached an agreement on two products targeting the toxic amyloid N3pE, including varoglutamstat (PQ912) in global clinical phase IIb and preclinical PBD-C06
.
In the field of autoimmunity, the company’s self-developed SIM0335 is the world’s first national class 1 new drug candidate that regulates fatty acid metabolism and acts on IL-17A-related pathways.
It aims to treat mild to moderate plaque psoriasis through external use.
Phase I clinical trials are currently underway
.
In other therapeutic areas, SIM1909-13 tablets (SIM0295), a highly selective and potent urate transfer protein 1 (URAT1) inhibitor, in cooperation with JW, are used in the treatment of gout with hyperuricemia, worldwide Phase IIb clinical trials have been completed within
.
15 varieties have been evaluated, and 5 major varieties are sprinting for the first imitation.
In the field of generic drugs, Simcere has closely followed the national policy, actively carried out consistency evaluation, and participated in the national centralized procurement
.
Source of the review status of Simcere Pharmaceuticals: Meinenet MED2.
0 Chinese Drug Evaluation Database At present, 15 varieties of Simcere Pharmaceuticals have passed or deemed to have passed the consistency evaluation, lenvatinib mesylate capsules, edaravone Injection, cefaclor dry suspension, meloxicam tablets, amoxicillin granules, montmorillonite powder are the first/exclusive reviews
.
In the research and development of generic drugs, Simcere's owners have taken the lead in imitation, especially the world's best-selling star products
.
At present, the company has 10 new classified products under review, and 5 of them have not yet been approved for listing (including the first imitation of dosage forms)
.
Simcere Pharmaceuticals has reported production and has no first copy approval of the varieties under review.
Source: Meinenet database.
Cabozantinib developed by Exelixis and Ipsen is a multi-target small molecule tyrosine kinase inhibitor.
Because of its extensive effectiveness against a variety of cancers, cabozantinib is known as the "magic oil" in targeted drugs
.
At present, the original products have not yet been approved to enter the domestic market.
Three domestic companies including Hausen, Osaikon, and Simcere have submitted listing applications under the new registration classification
.
Apomilast (apmilast/apmilast) is a new oral, small molecule phosphodiesterase 4 (PDE-4) inhibitor developed by New Base (acquired by Amgen), in 2014 Obtained FDA approval for listing, global sales in 2020 will reach 2.
195 billion US dollars
.
The original research product was approved for import in August 2021.
At present, 8 domestic companies have submitted applications for the listing of Apster tablets under the new classification
.
Adoxaban is a selective factor Xa inhibitor developed by Daiichi Sankyo.
It was first approved for venous thromboembolism in Japan in 2011, and has been approved for multiple new indications.
Global sales in 2020 154.
1 billion yen
.
The original research products were approved for import at the end of 2018.
Simcere and Nanjing Chia Tai Tianqing submitted applications for the listing of idoxaban tosylate tablets under the new registration classification, and Simcere was the first to submit for production
.
Ibrutinib, which was approved for marketing in the United States in 2013, is the only drug that has been designated by the FDA for three breakthrough treatments.
It is also the world's first Bruton's tyrosine kinase (BTK) inhibitor approved for marketing.
In 2020 Global sales reached 9.
442 billion U.
S.
dollars
.
The original research product was approved for import in August 2017, and the domestic sales in 2020 will exceed 1 billion yuan
.
At present, only Simcere has submitted an application for the marketing of Ibrutinib capsules in the category 4 imitations
.
Source: Meinenet database, public company announcements, etc.
Note: Meinenet China's urban entity pharmacy terminal competition pattern database covers entity pharmacies in 293 prefectures and cities across the country (excluding county and rural entity pharmacies), and continuously monitors the entire category Enlarged version of the city's physical pharmacy database
.
The above sales are calculated based on the average retail price of the product at the terminal
.
Statistics are as of November 19, if there are any omissions, please correct me!